Regulatory Affairs Specialist

EMEA Pharma Business Unit

At Brenntag the global market leader in chemicals and ingredients distribution were looking for a Regulatory Affairs Specialist to join our team in Barcelona o Valencia.

If youre passionate about regulatory compliance enjoy working in an international environment and want to make an impact by supporting regulatory excellence across the business wed love to hear from you.

Role Overview

As a key member of the Pharma team you will support the EMEA division on all regulatory quality compliance legal and product stewardship topics related to the supply of a large portfolio of raw materials into the pharmaceutical industry. Your primary responsibility is to provide accurate timely and auditready documentation to pharmaceutical customers and to support regulatory deliverables for bespoke product projects.

The role is primarily officebased with occasional travel required for supplier meetings customer visits audits or internal workshops.

You will collaborate closely with commercial supply chain QHSE and supplier partners to ensure that all materials supplied meet applicable pharmaceutical regulations and industry standards.

Customer Documentation & Regulatory Support

• Prepare review and issue technical and regulatory documentation required by pharmaceutical customers including:
  • Quality & Technical Agreements
  • Supply Chain Statements
  • Regulatory Questionnaires
  • Compliance Statements (e.g. TSE/BSE GMO allergens nitrosamines residual solvents elemental impurities)
• Ensure all documentation is accurate consistent and aligned with applicable frameworks (i.e. relevant pharmacopoeia IPEC Guidelines EU GDP and GMP guidelines.

Information Gathering & Supplier Engagement

• Source regulatory quality and technical information internally and from suppliers to fulfil customer requests.
• Evaluate supplier documentation for completeness compliance and suitability for pharmaceutical use.

Customer Request Management

• Log track and report customer documentation requests using defined KPIs.
• Support continuous improvement by identifying trends gaps and opportunities to streamline documentation processes.

Support for Customer Value Added Service Projects

• Lead and manage regulatory deliverables for customer-specific projects.
• Coordinate regulatory assessments supplier data collection and compliance documentation for new product introductions or customised specifications.
• Support change control evaluations and customer notifications.

Regulatory Compliance & Standards Implementation

• Work with QHSE and supply chain teams to ensure compliance with applicable standards (IPEC GMP/GDP EXCiPACT GDP and other regulatory frameworks).
• Support implementation of new regulatory requirements and internal standards across the business unit.

Cross-Functional Collaboration

• Partner with commercial and value-added services teams to provide regulatory expertise for customer projects and commercial initiatives.
• Contribute to global Pharma Regulatory team projects harmonisation efforts and continuous improvement activities.

Training & Knowledge Sharing

• Deliver training to commercial supply chain and internal teams on regulatory topics relevant to supply of materials into the pharmaceutical industry.
• Act as a subject matter expert for documentation compliance and regulatory expectations.

Additional Responsibilities

• Perform any other tasks within capability to support the commercial regulatory and compliance success of the Pharma business unit.

Qualifications & Experience

• Degree in a life science discipline (chemistry biochemistry pharmaceutical sciences) or equivalent relevant experience.
• Strong knowledge of pharmaceutical industry requirements for APIs excipients biopharma materials and traditional pharma raw materials.
• Understanding of European National Competent Authority requirements for distribution of APIs excipients and raw materials.

Skills & Competencies

• Fluent in English and Spanish (spoken and written).
• Strong written communication skills with the ability to produce clear accurate and compliant documentation.
• Excellent collaboration skills with the ability to work proactively across all levels and functions.
• Ability to interpret regulations resolve compliance issues and respond to complex regulatory queries.
• High attention to detail and strong organisational skills.
• Willingness to undertake occasional travel for customer meetings supplier visits audits or internal workshops.

Interested in joining us or know someone who might be a great fit Wed love to hear from you! Feel free to apply or share this opportunity with your network.

Brenntag provides equal employment opportunities to qualified applicants and employees of all backgrounds and identities to create a workplace where difference is valued because it forms a resilient and more innovative organization. We do not discriminate on the basis of age disability gender identity sexual orientation ethnicity race religion or belief parental and family status or any other protected characteristic. We welcome applications from women men and non-binary candidates of all ethnicities and socio-economic backgrounds.